Smart Vial Adapter and Method

ABSTRACT

A smart vial adapter is capable of measuring the dose of a drug that is withdrawn from a vial, measuring the time of a dose capture event, monitoring the vial temperature, measuring the amount of motion or perturbation the vial is subjected to, capturing various other parameters that can provide additional insights associated with the drug or the amount of the dose being drawn from the vial, and communicating the recorded information to a companion application on a computer, smartphone or other device. Related methods are also disclosed and claimed.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority under 35 U.S.C. 119(e) to U.S.provisional application Ser. No. 62/616,688, filed on Jan. 12, 2018,which is incorporated herein in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to vial adapters and dosecapture systems. In particular, but not by way of limitation,embodiments of the present invention relate to a smart vial adapter thatis capable not only of providing physical access to a drug vial, butalso of performing dose capture, condition monitoring and informationreporting functions using electronic components contained within thevial adapter. Related methods are also disclosed and claimed.

BACKGROUND OF THE INVENTION

Effective administration of some types of drug injections, particularlyin the case of insulin used by diabetics, requires that the drug be keptunder proper storage conditions and that a record of all administereddoses be kept. While education is offered for home injection patients,most patients still find it challenging to follow the instructionsproperly on a daily basis. Health care personnel can record dose-relatedinformation in a clinical setting, but there is significant overheadassociated with capturing this information. It is also difficult tomeasure and record certain parameters that can affect the safety andefficacy of the drug, such as drug temperature and proper mixing.

Many types of drugs are provided in vials that contain multipleindividual doses. The vial is sealed by a rubber septum that can bepierced by a syringe needle when a dose of the drug is drawn from thevial into the syringe in preparation for an injection. If, instead of aneedle, the syringe has a blunt cannula or Luer tip that is incapable ofpiercing the septum, a vial adapter can be used to allow the syringe toaccess the vial. The vial adapter has a sharp plastic spike or cannulathat pierces the septum, and a fluid port, typically in the form of aneedleless valve or pre-slit septum, that can be accessed by the bluntcannula or Luer tip of the syringe. The vial adapter can be left inplace after it is installed on the vial, allowing multiple doses to bedrawn from the vial without repeatedly penetrating the vial septum.

Most vial adapters are entirely mechanical nature, providing only afluid path between the vial and a syringe, and a secondary seal for thevial. However, the physical presence of the vial adapter on the vial,and its interposition in the fluid path between the vial and thesyringe, provides the opportunity for the vial adapter to performadditional functions such as dose capture, condition monitoring andinformation reporting. The present invention addresses this opportunityby providing a vial adapter with electronic components that allow it toperform these and/or other functions. Related methods are also disclosedand claimed.

SUMMARY OF EMBODIMENTS OF THE INVENTION

In accordance with embodiments of the present invention, a vial adapteris provided that is capable not only of providing physical access to adrug vial, but also of performing dose capture, condition monitoring andinformation reporting functions using electronic components containedwithin the vial adapter. These functions can include measuring the dosedrawn from the vial, measuring the time of a dose capture event,monitoring the vial temperature, measuring the amount of motion orperturbation the vial is subjected to, capturing various otherparameters that can provide additional insights associated with the drugor the amount of the dose being drawn from the vial, and communicatingthe recorded information to a companion application on a computer,smartphone or other device.

More specifically, one embodiment of the present invention relates to avial adapter comprising a housing having first and second ends, thefirst end being open and attachable to a vial, the second end having afluid port sealed by a penetrable septum; a vial access cannula affixedto the housing and communicating with the fluid port, the vial accesscannula being positioned within the open first end of the housing forpenetrating the septum of a vial attached to the housing; and electricalcomponents contained within the housing for performing at least one dosecapture, condition monitoring or information reporting function withrespect to a drug that is contained in or drawn from a vial attached tothe housing.

In another embodiment of the present invention, a method for storing andusing a drug contained in a vial comprises attaching to the vial anadapter that is capable of performing at least one dose capture,condition monitoring or information reporting function with respect tothe drug while the drug is contained in the vial or is drawn from thevial through the adapter; and causing the vial adapter to performing theat least one dose capture, drug monitoring or condition reportingfunction with respect to the drug while the drug is contained in thevial or is drawn from the vial through the adapter.

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects and advantages of embodiments of the invention will be morereadily appreciated from the following detailed description, taken inconjunction with the accompanying drawings, in which:

FIG. 1 is a schematic view illustrating a drug vial, a smart vialadapter that is attachable to the drug vial, and a mobile device thatwirelessly receives information from the smart vial adapter;

FIG. 2 is a schematic view similar to that of FIG. 1, but with the smartvial adapter attached to the drug vial, a syringe positioned for drawinga dose from the vial through the smart vial adapter, and the mobiledevice not shown;

FIG. 3 is a detailed cross-sectional view of the smart vial adapter,shown detached from the drug vial;

Fig.4 is a schematic diagram of the electronic components within thesmart vial adapter that perform various dose capture, conditionmonitoring and information reporting functions;

FIGS. 5 and 6 are flow charts of the operations performed by the smartvial adapter while operating in its sleep and active modes,respectively; and

FIGS. 7-9 are exemplary screen displays that can be produced by a mobiledevice that is programmed with a software application associated withthe smart vial adapter.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION

Reference will now be made in detail to embodiments of the presentinvention, which are illustrated in the accompanying drawings, whereinlike reference numerals refer to like elements throughout. Theembodiments described and illustrated herein exemplify, but do notlimit, the present invention, and the drawings are not necessarily toscale with respect to each other or with respect to actual physicalembodiments. Further, it will be understood by one skilled in the artthat the phraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including,” “comprising,” or “having” and variations thereof herein ismeant to encompass the items listed thereafter and equivalents thereofas well as additional items. Unless limited otherwise, the terms“connected,” “coupled,” and “mounted,” and variations thereof herein areused broadly and encompass direct and indirect connections, couplings,and mountings. In addition, the terms “connected” and “coupled” andvariations thereof are not restricted to physical or mechanicalconnections or couplings. Further, terms such as “up”, “down”, “bottom”,“top”, “distal” and “proximal” are relative, and are employed to aidillustration, but are not limiting.

FIGS. 1 and 2 are schematic views of the overall combination of elementsemployed in one embodiment of the present invention. A conventionalglass or plastic drug vial 10 containing insulin or another injectabledrug in liquid form is sealed by an upper cap 12 having a rubber septum14. A smart vial adapter 16 that wirelessly communicates a smartphone 11or other mobile electronic device is attachable to the vial 10. The vialadapter 16 has a cylindrical plastic housing 17 and a vial accesscannula in the form of a downwardly projecting, hollow plastic spike 18with a sharp tip 21. The housing 17 is attachable over the cap 12 toprovide fluidic access to the interior of the vial 10 for the purpose offilling a syringe 19.

The vial 10 and vial adapter 16 are shown separated from each other inFIG. 1, as would be the case prior to the vial adapter 16 beinginstalled on the vial 10 or after its removal from the vial 10. In FIG.2, the vial 10 and vial adapter 16 are shown connected to each other, asthey would be during syringe filling. In the connected state, the spike18 penetrates the vial septum 14 in a fluid-tight manner to communicatewith the interior of the vial 10. In addition, an integral lower skirt20 of the vial adapter housing 17 is received over the vial cap 12, andan inwardly projecting stabilizing ring 22 of the skirt 20 is engagedwith an annular groove 24 beneath the cap 12 to provide a releasablesnap or detent connection between the vial 10 and vial adapter 16. Theplastic material of the vial adapter housing 17 and skirt 20 issufficiently flexible and resilient to allow for the releasable snap ordetent connection between the vial 10 and vial adapter 16.

When the vial 10 and vial adapter 16 are connected to each other asshown in FIG. 2, the syringe 19 can be filled with a dose of the drugcontained in the vial 10, via the vial adapter 16, in much the samemanner as when a syringe is filled from a vial directly. Initially, theconnected vial 10 and vial adapter 16 are inverted to allow the liquiddrug to flow from the vial 10 through the inner lumen of the spike 18into a cylindrical chamber 26 within the housing 17 of the vial adapter16. A rubber septum 28 seals the chamber 26 to provide sterility and toprevent leakage of air or liquid from (or into) the chamber 26 duringsyringe filling. Once the chamber 26 is filled, the plunger 30 of thesyringe 19 (which is not yet engaged with the vial adapter 16) is pulledback to fill the syringe barrel 32 with an amount of air correspondingto the dose of the drug that is to be withdrawn from the vial 10. Thesharp tip 34 of the hollow metal syringe needle 36 is then pushedthrough the septum 28 of the vial adapter 16, bringing the inner lumenof the hollow needle 36 into fluid communication with the interior ofthe chamber 26 containing the liquid drug. The plunger 30 of the syringe19 is then depressed to inject the air into the chamber 26.

Since the connected vial 10 and vial adapter 16 are still inverted atthis time, the air will move immediately into the vial 10 and thechamber 26 will refill with the liquid drug. As in the conventionalsyringe filling procedure (i.e., without the vial adapter 16), theinitial injection of air into the vial 10 compensates for the liquidthat is to be removed from the vial 10 and thus prevents the formationof a vacuum in the vial 10 when the syringe 19 is filled. After the airinjection, and with the connected vial 10 and vial adapter 16 stillinverted, the plunger 30 of the syringe 19 is pulled back once again towithdraw the desired amount of liquid drug from the chamber 26 into thesyringe barrel 32. As the liquid drug is removed from the chamber 26,the sealed chamber 26 refills with an equal amount of liquid drug fromthe vial 10 through the inner lumen of the spike 18. The filled syringe19 can then be used to inject the drug directly into the body of apatient, or into an IV line through a PRN or other type of medical port.

FIG. 3 is a detailed cross-sectional view of the smart vial adapter 16,shown detached from the drug vial 10. As illustrated, the chamber 26communicates with the inner lumen 36 of the spike 18 through an opening38 at the bottom of the chamber 26, allowing air and liquid to movefreely in either direction between the chamber 26 and the interior ofthe vial 10. Surrounding the chamber 26 is an annular cavity 40containing various electronic components 42 that allow the smart vialadapter 16 to perform its dose capture, condition monitoring andinformation reporting functions, as discussed in more detailhereinafter. One or more access doors or plates (not shown) can beprovided to allow the components 42 to be installed in the cavity 40during initial manufacture of the smart vial adapter 16, and to allowfor replacement of the battery that powers these components. A smallerannular cavity 44 is formed in surrounding relationship with, andopening into, the inner lumen 36 of the spike 18. This cavity containsone or more electronic flow sensors 46 which are capable of measuringliquid flow within the lumen 36 so that the volume of the liquid drugpassing through the lumen 36 during syringe filling can be measured orcalculated. This allows the smart vial adapter 16 to perform its dosecapture function (i.e., to determine how much of the liquid drug iswithdrawn from the vial, and by inference how much of the liquid drug isinjected by the user, at a particular time or during a particularinterval). The flow sensors 46 are preferably hybrid thermal time offlight (TTOF) flow sensors of the type disclosed in detail in commonlyassigned U.S. patent application Ser. No. 15/226,638, filed on Aug. 2,2016 and published on Feb. 8, 2018 as U.S. Patent ApplicationPublication No. 2018/0036495, which is incorporated herein by referencein its entirety. However, other types of thermal and non-thermal flowsensors can also be used.

During the last part of the syringe filling procedure described above,when the liquid drug is being drawn into the syringe barrel 32 from thechamber 26 of the inverted vial adapter 16, the chamber 26 is completelyfilled with the liquid drug. As a result, the amount of liquid drugtransferred from the chamber 26 into the syringe 19 is replaced by anequal amount of liquid drug that is drawn from the vial 10 into thechamber 26 through the inner lumen 36 of the spike. Since the fluidpassing through the lumen 36 flows past the flow sensors 46, thisquantity can be calculated based on the measured flow rate and theelapsed time. The calculated quantity represents the dose of the drugthat is transferred to the syringe 19 and injected by the user.

FIG. 3 also illustrates that the septum 28, instead of being solid, maybe pre-formed with a slit 48 that allows it to be penetrated by a bluntcannula or Luer tip. This may be preferred when the drug that iswithdrawn from the vial 10 is intended to be transferred to an IV linethrough a needleless valve or needleless injection site, rather thanbeing injected into the skin with a needle. In this case the syringe 19of FIG. 2 is provided with a Luer fitting or blunt cannula, in lieu ofthe needle 36.

FIG. 4 is a schematic diagram of the electronic components 42 within thesmart vial adapter that perform the dose capture function justdescribed, as well as other condition monitoring and informationreporting functions. These components include a microcontroller 50 withan internal time-of-day clock, the previously described flow sensor(s)46, a memory 52 for storing programming and data used by themicrocontroller 50, a thermal sensor 54 for detecting the ambienttemperature (and by inference the temperature of the vial 10 and itscontents), an accelerometer 56 for measuring the amount of motion orperturbation the vial adapter 16 (and by inference the vial 10 and itscontents) is subjected to, a Bluetooth module 58 for wirelesslycommunicating with the smartphone 11 or other external electronic device(such as a computer or tablet), one or more visual indicators 60 such asdifferently colored LEDs, one or more audible or tactile indicators 62such as beepers, buzzers, speakers or vibrating devices, one or morepushbuttons 64, and a microswitch 66 that senses the initial connectionof the vial adapter 16 to the vial 10. A power supply 68, typically inthe form of a replaceable or rechargeable DC battery and suitablevoltage regulating circuitry, supplies power to the microcontroller 50and to any of the other components of FIG. 4 that require electricalpower.

FIG. 5 is a flow chart of the operations performed by themicrocontroller 50 while the smart vial adapter 16 is operating in itssleep mode. This is the normal or default operating mode of the vialadapter 16 when it is not being used. In step 70, the microcontroller 50records the ambient temperature using the thermal sensor 54 and storesthe recorded value in the memory 52. In step 72, the microcontroller 50records any motion or agitation that the vial adapter 16 may beundergoing, using the accelerometer 56, and stores the recorded value inthe memory 52. In step 74, the microcontroller 50 records the currenttime of day and stores the recorded value in the memory 52 with theassociated temperature and motion readings. The time, temperature andmotion readings provide time-temperature and agitation data that can beused to verify that the drug has been stored at the proper temperature,that is has been properly mixed prior to use, and that is has notexpired. In step 76, an alert is sounded using the visual and/or audibleindicators 60, 62 either when it time for the user to receive a dose ofthe drug, or when a condition is detected that requires intervention bythe user. Such conditions can include a temperature that is too high ortoo low over an extended period of time, a lack of movement of the vialadapter 16 for a sufficient amount of time that the drug may requireagitation or mixing before use, or expiration of the drug in the vial10. The steps 70-76 are performed repeatedly, at a predeterminedsampling frequency (e.g., once per minute) while the smart vial adapter16 is operating in its sleep mode.

FIG. 6 is a flow chart of the operations performed by themicrocontroller 50 while the smart vial adapter 16 is operating in itsactive mode. This is the operating mode in which the vial adapter 16 isplaced, either by an intentional user input (e.g., depression of one ofthe pushbuttons 64), or by a sensed condition such as sudden movement(detected by the accelerometer 56), when the vial adapter is about to beused for an injection. In step 80, a check is made to determine if thedrug has expired by comparing the current time with a predeterminedstart time. The predetermined start time can be defined, for example, bya user input such as depression of another one of the pushbuttons 64, orby the microswitch 66 sensing the initial connection of the vial adapter16 to the vial 10. In steps 82 and 84, checks are made to determine ifthe drug is at the proper temperature for use and (based on prioragitation history) whether further mixing of the drug is needed. Iffurther mixing is needed, the user is alerted to this using the visualand/or audible indicators 60, 62, and in step 86, a check is made toconfirm that the user has in fact provided adequate mixing. The userthen proceeds to fill the syringe 19 from the vial adapter 16 using theprocedure previously described. In step 88, the microcontroller 50calculates the dose that is drawn from the chamber 26 into the syringe19 (with compensation for any dead space within the syringe) using thedata from the flow sensor(s) 46. If desired, the audible indicator 62can be made to produce beeps of increasing frequency and/or intensity asthe draw nears a preset volume. In step 90, the calculated dose volumeis stored in the memory 52, along with the corresponding temperature,time of day, and any other desired information. If an active Bluetoothconnection is detected, this dose capture data is also transmitted tothe smartphone application using the Bluetooth module 58. The vialadapter then re-enters the sleep mode until the next dosing event isdetected. Each time that a dose is drawn from the vial 10 through thevial adapter 16, the active mode of FIG. 6 is re-entered and the steps80-90 are repeated.

FIGS. 7-9 are exemplary screen displays that can be produced on asmartphone 11 or other mobile device that is programmed with a softwareapplication associated with the smart vial adapter 16. In theillustrated example, the drug being administered is insulin and the useris assumed to have entered or imported his or her blood glucosemeasurements into the smartphone application for processing along withthe measured dose capture data from the vial adapter 16. In FIG. 7, thedisplayed information includes the user's statistics for the currentday, including the number 100 of injections administered, the percentage102 of blood glucose measurements within a desired range, a bar chart104 showing the amount of insulin (e.g., the number of units or thevolume in milliliters) administered in each injection, and a line chart106 showing blood glucose level over time. In FIG. 8, an events panel108 is added to the display to pair blood glucose measurements withinjection events. In FIG. 9, the user's statistics over a 7-day periodare displayed. These include estimated A1c level 110 based on injectionand glucose data for the 7-day period, the total number and dailyaverage 112 of blood glucose measurements over the 7-day period, thenumber 116 of in-range, below-range and above-range blood glucosemeasurements making up the 7-day total, and the number 118 of balanced,hypoglycemic and hyperglycemic days within the 7-day period.

In an alternative embodiment that is not illustrated in the drawings, anelectrically powered air pump and air filter may incorporated into thehousing 17 of the vial adapter 16 to force filtered air into the vial 10before a dose of the liquid drug is drawn into the syringe 19 from thevial 10. This eliminates the need for the user to manually perform thisinitial step using the syringe 19. Additional details concerning thisembodiment can be found in a commonly assigned U.S. patent applicationof Tianqi Hang and Uzair Siddiqui filed on Jul. 31, 2018 and entitled“Medication Dispensing System” (Attorney Docket No. P-16028/66810-2749),which is incorporated herein by reference in its entirety.

Although only a few embodiments of the present invention have been shownand described, the present invention is not limited to the describedembodiments. Instead, it will be appreciated by those skilled in the artthat changes may be made to these embodiments without departing from thescope of the invention. In addition, any of the embodiments, featuresand/or elements disclosed herein may be combined with one another toform various additional combinations not specifically disclosed, as longas the embodiments, features and/or elements being combined do notcontradict each other. All such changes and combinations are consideredto be within the scope of the invention as defined by the appendedclaims and their equivalents.

What is claimed is:
 1. A vial adapter comprising: a housing having first and second ends, the first end being open and attachable to a vial, the second end having a fluid port sealed by a penetrable septum; a vial access cannula affixed to the housing and communicating with the fluid port, the vial access cannula being positioned within the open first end of the housing for penetrating the septum of a vial attached to the housing; and electrical components contained within the housing for performing at least one dose capture, condition monitoring or information reporting function with respect to a drug that is contained in or drawn from a vial attached to the housing.
 2. The vial adapter of claim 1, wherein the dose capture, condition monitoring or information reporting function is selected from the group consisting of measuring a quantity of the drug drawn from the vial, measuring a time when the drug is drawn from the vial, monitoring the temperature of the vial, measuring motion of the vial, producing a visual indication, producing an audible indication, and wirelessly communicating information to an external device.
 3. The vial adapter of claim 1, wherein the electrical components contained within the housing include one or more of a flow sensor, a thermal sensor, an accelerometer, a microcontroller, a visual indicator , an audible indicator and a Bluetooth module.
 4. The vial adapter of claim 1, wherein the electrical components contained within the housing include a flow sensor positioned adjacent to an internal lumen of the vial access cannula for sensing fluid flow within the vial access cannula.
 5. The vial adapter of claim 4, wherein the flow sensor comprises a thermal time of flight (TTOF) flow sensor.
 6. The vial adapter of claim 1, wherein the housing includes an internal fluid chamber between the fluid port and the vial access cannula, the internal chamber being sealed by the septum and communicating with an internal lumen of the vial access cannula.
 7. The vial adapter of claim 6, wherein the electrical components are received in an internal cavity of the housing that is adjacent to the internal fluid chamber.
 8. The vial adapter of claim 7, wherein the internal cavity at least partially surrounds the internal fluid chamber.
 9. The vial adapter of claim 8, wherein the housing and the internal fluid chamber are each generally cylindrical, and wherein the internal cavity is generally annular.
 10. The vial adapter of claim 1, wherein the septum comprises a solid septum that is penetrable by a syringe needle.
 11. The vial adapter of claim 1, wherein the septum comprises a pre-slit septum that is penetrable by a blunt cannula or a Luer tip.
 12. A method for storing and using a drug contained in a vial, comprising: attaching to the vial an adapter that is capable of performing at least one dose capture, condition monitoring or information reporting function with respect to the drug while the drug is contained in the vial or is withdrawn from the vial through the adapter; causing the vial adapter to performing the at least one dose capture, condition monitoring or information reporting function with respect to the drug while the drug is contained in the vial or is withdrawn from the vial through the adapter.
 13. The method of claim 12, wherein the dose capture, condition monitoring or information reporting function is selected from the group consisting of measuring a quantity of the drug drawn from the vial, measuring a time when the drug is drawn from the vial, monitoring the temperature of the vial, measuring motion of the vial, producing a visual indication, producing an audible indication, and wirelessly communicating information to an external device.
 14. The method of claim 12, wherein the vial adapter includes a flow sensor, and wherein the function comprises a dose capture function performed by measuring a quantity of drug withdrawn from the vial using the flow sensor.
 15. The method of claim 12, wherein the vial adapter includes a Bluetooth module, and wherein the function comprises an information reporting function performed by wirelessly communicating information to an external device using the Bluetooth module.
 16. The method of claim 15, wherein the information is selected from the group consisting of dosage amount, dosage time, vial temperature and vial motion.
 17. The method of claim 15, wherein the external device comprises a computer, a smartphone or a mobile device containing a software application for processing said information and providing a user output.
 18. The method of claim 17, wherein the user output comprises a visual or graphical display of one or more of the following: (a) the number of doses withdrawn from the vial during a predetermined period of time; (b) the dosage amount for each of a plurality of doses withdrawn from the vial during a predetermined period of time; (c) dosage events paired with contemporaneously measured physiological data; and (d) estimated or projected physiological data based on dosage history.
 19. The method of claim 18, wherein the drug comprises insulin and the physiological data comprises glucose level or A1c level.
 20. A method for storing and using a drug contained in a vial, comprising: attaching to the vial an adapter as claimed in claim 1; causing the vial adapter to performing the at least one dose capture, condition monitoring or information reporting function with respect to the drug while the drug is contained in the vial or is withdrawn from the vial through the adapter. 